Remote Interlock Connector Requirements for Laser Products
This guidance clarifies the requirements for remote interlock connectors in laser products, specifically addressing whether power cable connections can serve as remote control connectors under 21 CFR 1040.10(f)(3).
What You Need to Know? 👇
What is the purpose of a remote interlock connector in laser products?
A remote interlock connector provides a means to connect an optional remote interlock switch or control external to the laser product. When terminals are not electrically joined, it prevents human access to laser and collateral radiation, serving as a safety feature.
Can a primary power cable connector serve as a remote interlock connector?
No, a primary electrical power cable connector for battery, AC converter, or mains power does not satisfy the remote interlock connector requirement under 21 CFR 1040.10(f)(3). It must be a separate, independent performance feature specifically for remote control purposes.
What happens when remote interlock connector terminals are disconnected?
When the terminals of the remote interlock connector are not electrically joined, human access to all laser and collateral radiation from the product must be prevented according to 21 CFR 1040.10(f)(3).
Is a shorting plug acceptable for remote interlock connectors?
Yes, the connector may be supplied with a shorting plug to complete the circuit when remote control is not used. However, the necessary mating plug for connecting optional remote controls must be commercially available.
What makes a remote interlock connector “satisfactory” under FDA requirements?
A satisfactory remote interlock connector must be readily identifiable for its purpose, function as a separate independent feature, and have commercially available mating plugs for connecting optional remote interlock switches or controls.
Does connecting to battery power count as “electrically joining” terminals?
No, connecting terminals to battery or supply mains is not considered “electrically joining” in the regulatory sense. The standard implies simple connection between terminals themselves, not connection to external power sources.
What You Need to Do 👇
Recommended Actions
- Ensure laser products include a dedicated remote control connector separate from power connections
- Implement proper prevention of laser and collateral radiation access when connector terminals are not joined
- Make the remote control connector clearly identifiable for its purpose
- Verify commercial availability of necessary mating plugs for remote interlock connections
- Consider providing shorting plugs with the product for when remote control feature is not in use
- Document compliance with 21 CFR 1040.10(f)(3) requirements in technical documentation
- Include remote control connector specifications in product design requirements
Key Considerations
Safety
- Primary electrical power cable connectors (for power line mains, battery, or converter box) do not satisfy remote control connector requirements
- When connector terminals are not electrically joined, all laser and collateral radiation access must be prevented
- The remote control connector must be a separate, independent performance feature
- The connector must be readily identifiable for its intended purpose
- A shorting plug may be supplied to complete the circuit when remote control feature is not in use
Other considerations
- The necessary mating plug for connecting optional remote interlock switch or control must be commercially available
- The connector must allow for connection of optional remote interlock switch or other appropriate external control
- The remote control connector must be separate from power supply connections
Relevant Guidances đź”—
- Laser Products - Performance Standards and Safety Requirements
- Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 Standards
Related references and norms đź“‚
- 21 CFR 1040.10: Performance Standards for Light-Emitting Products